Dornier Medtech America, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Delta III Pro510(k)Feb 22, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 22, 2023
Dornier Thulio510(k)Jul 27, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 27, 2022
Nautilus510(k)Apr 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 18, 2022
Electrosurgical accessory510(k)May 19, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 19, 2021